It was reported that on (b)(6) 2023, a patient presented with grade 4+ functional mitral regurgitation (mr) for a mitraclip procedure.During the procedure, the patient's blood pressure dropped, cardiopulmonary resuscitation (cpr) was performed, and medication was administered by anesthesiology.One clip was able to be implanted and the mr was reduced to grade 1.On december 20, 2023, the physician disclosed that they saw air in the aorta and believed it was due to the steerable guide catheter (sgc), but there was no leak/air observed in the device.The procedure was delayed until the patient was stable.There was no harm due to the delay.There were no adverse patient sequelae.
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The device was not returned for evaluation.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to the reported event.Based on the information reviewed, a cause for the reported air embolism resulting in hypotension cannot be determined; however, embolism (air) and hypotension are listed in the instructions for use (ifu) as known possible complications associated with mitraclip procedures.Unexpected medical intervention and medication required were a result of case-specific circumstances.There is no indication of a product issue with respect to manufacture, design or labeling.
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